FDA proposes new regulations on animal drugs

SILVER SPRING, MD. — On March 8, the US Food and Drug Administration (FDA) proposed new regulations on animal drugs, aiming to provide animal drug sponsors with predictable requirements for the labeling of new prescription and over-the-counter (OTC) animal drugs, as well as those for use in animal feed. According to the administration, the proposed regulations would not only benefit veterinarians, but also animal/pet owners and animal producers by providing more consistent information on the safe and effective use of new drugs.

According to the FDA, it has followed certain practices for reviewing animal drug labels in the past. However, these practices have not been codified in regulation.

“The lack of direction regarding format and content for each component of labeling has resulted in confusion for sponsors as they prepare labeling for FDA’s review and sometimes results in poor quality labeling submissions,” the agency said. “Poor quality labeling submissions increase the time needed by sponsors to revise and resubmit adequate labeling, and they increase time needed by FDA to review and approve labeling, and consequently, the application.”

Additionally, the FDA is proposing to amend or remove certain current regulations to help ensure consistency with these new animal drug label regulations. This would place all labeling requirements on content and format of approved or conditionally approved new animal drugs in the Code of Federal Regulations under one location.

“New animal drug labeling that presents information in an inconsistent manner can contribute to medication errors by making it difficult for veterinarians and animal owners to readily locate and understand critical directions and safety information,” the agency added.

If the new regulations are finalized, future animal drug applications would have to comply, whereas previously approved new animal drugs would need to comply over a staggered schedule during the course of six years.

The FDA is currently accepting public comments on the new proposed animal drug regulations until June 10, before working on a final version of the new rules. Comments can be submitted via the Federal eRulemaking Portal or mailed.

“If finalized, the rule would create for the first time a comprehensive set of regulations establishing requirements for content and format of the labeling for approved and conditionally approved new animal drugs and would also help animal drug sponsors more efficiently prepare labeling for review,” the agency claimed.

Read more on the new animal drug regulations here.

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